Preschooler Emotion Regulation in the Context of Maternal Borderline Personality Disorder
Primary Purpose
Borderline Personality Disorder, Emotional Problem
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dialectical Behavior Therapy Skills
Sponsored by
About this trial
This is an interventional treatment trial for Borderline Personality Disorder
Eligibility Criteria
Inclusion Criteria:
- Have a child who is 3 years old; have custody of child; endorse at least 3 symptom criteria of BPD in which one symptom must be affective instability and uncontrollable anger; have a verbal IQ of at least 70
Exclusion Criteria:
- Does not have custody of child; child has known developmental disabilities; mother is psychotic; mother has suicidal ideation + an active plan; mother has low verbal IQ
Sites / Locations
- University of Pittsburgh Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Dialectical Behavior Therapy Skills
Family Services as Usual
Arm Description
Dialectical Behavior Therapy SKills; 2.5 hour group session/week; 1 year
Mothers will continue with services they are receiving in the community
Outcomes
Primary Outcome Measures
Maternal emotion dysregulation
Difficulties with Emotion Regulation Scale
Secondary Outcome Measures
Full Information
NCT ID
NCT03060902
First Posted
February 17, 2017
Last Updated
November 23, 2022
Sponsor
University of Oregon
Collaborators
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT03060902
Brief Title
Preschooler Emotion Regulation in the Context of Maternal Borderline Personality Disorder
Official Title
Preschooler Emotion Regulation in the Context of Maternal Borderline Personality Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 23, 2017 (Actual)
Primary Completion Date
May 4, 2022 (Actual)
Study Completion Date
May 4, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oregon
Collaborators
University of Pittsburgh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Offspring of mothers with Borderline Personality Disorder (BPD) are at serious risk for developing mental illness at every stage of their life, and yet little is known about how this risk is transmitted. This study will leverage Dialectical Behavior Therapy Skills as an experimental intervention to determine if preschool emotion regulation develops more rapidly as a result of improvements in mothers' ability to regulate her own emotions. The knowledge from this study will identify a modifiable pathway by which maternal BPD places offspring at risk for later mental disorders and will quantify how much improvement in children's ability to regulate their emotions can be achieved by treating mothers alone.
Detailed Description
Borderline personality disorder is a serious mental illness characterized by extreme emotions, chaotic interpersonal relationships, suicidal behaviors, and a poor sense of self. Offspring of mothers with Borderline Personality Disorder (BPD) are at an elevated risk for developing mental illness across the lifespan. Difficulty managing emotions are a hallmark feature of BPD, and yet the ability to do so is necessary for responding effectively to childrens' emotions. This process is called maternal emotion socialization, which has a major impact on how children develop their own emotion regulation (ER) skills. ER develops rapidly during preschool and deficits in preschool ER are recognized as underlying future mental disorders. This proposal will test a model examining the extent to which maternal ER and emotion socialization impact child ER, which may be a significant pathway by which mental health problems are transmitted to offspring of mothers with BPD. This proposal will leverage Dialectical Behavior Therapy (DBT) Skills training, a robust and effective method for improving ER as a tool to change maternal ER in mothers with BPD. By completing multiple assessments of biobehavioral markers of child and mother ER, this study is poised to uncover a potentially modifiable pathway by which these offspring are at risk. Specifically, the investigators propose to conduct a stratified randomized controlled trial of DBT Skills for mothers with BPD who have preschoolers. A total of 300 dyads (initial child age: 36-54 months) will be collected in Eugene, Oregon and Pittsburgh Pennsylvania, with 100 pairs in each of three groups: children who have mothers with BPD who receive DBT Skills, children who have mothers with BPD who receive Family Services as Usual, and children who have non-disordered mothers, matched on income, with this final group only participating in assessments (as to quantify normative ER growth). All children will be assessed 4 times every 2-months, with the first assessment occurring prior to treatment assignment. Investigators will use a biobehavioral laboratory battery to measure child ER, assessing emotion understanding, strategy use, attention regulation and inhibitory control, and parasympathetic regulation. In mothers, a similar multi-method approach to assess emotion acceptance, strategy use, recognition, and parasympathetic regulation will be employed. Finally, during each laboratory assessment, there will be observations of mother's ability to effectively respond to children in the context of child negative emotions. Growth curve modeling will chart child ER trajectories for all 3 groups so that investigators can compare child ER growth as a function of: group status (DBT Skills vs. Family Services as Usual vs. income matched, non-disordered controls), changes in maternal ER, and changes in maternal emotion socialization. Findings from this proposal will identify a modifiable pathway by which offspring of mothers with BPD are at risk, determine the extent to which child ER can be restored by treating mothers, and will be the first DBT Skills trial to measure outcomes in offspring.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder, Emotional Problem
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dialectical Behavior Therapy Skills
Arm Type
Experimental
Arm Description
Dialectical Behavior Therapy SKills; 2.5 hour group session/week; 1 year
Arm Title
Family Services as Usual
Arm Type
No Intervention
Arm Description
Mothers will continue with services they are receiving in the community
Intervention Type
Behavioral
Intervention Name(s)
Dialectical Behavior Therapy Skills
Intervention Description
DBT Skills Training will follow the DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition.
Primary Outcome Measure Information:
Title
Maternal emotion dysregulation
Description
Difficulties with Emotion Regulation Scale
Time Frame
1 year
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
The study requires participants be mothers.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have a child who is 3 years old; have custody of child; endorse at least 3 symptom criteria of BPD in which one symptom must be affective instability and uncontrollable anger; have a verbal IQ of at least 70
Exclusion Criteria:
Does not have custody of child; child has known developmental disabilities; mother is psychotic; mother has suicidal ideation + an active plan; mother has low verbal IQ
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maureen Zalewski, Ph.D.
Organizational Affiliation
University of Oregon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephanie Stepp, Ph.D.
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
NIMH NDA
IPD Sharing Time Frame
See NIMH NDA
IPD Sharing Access Criteria
See NIMH NDA
Learn more about this trial
Preschooler Emotion Regulation in the Context of Maternal Borderline Personality Disorder
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